XeroBurn Sterile Burn Dressing Blanket 70" x 95"

GUDID 00840117333048

70" x 95"

DYNAREX CORPORATION

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Primary Device ID00840117333048
NIH Device Record Keyb9578e76-5974-4b66-8024-2eeb48189508
Commercial Distribution StatusIn Commercial Distribution
Brand NameXeroBurn Sterile Burn Dressing Blanket 70" x 95"
Version Model Number1339
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117333048 [Package]
Contains: 00840117333055
Package: MC Master [1 Units]
In Commercial Distribution
GS100840117333055 [Primary]

FDA Product Code

NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-02
Device Publish Date2024-03-25

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00840117333024 - XeroBurn Sterile Burn Dressing Blanket 60"x 70"2024-04-02 60"x 70"
00840117333048 - XeroBurn Sterile Burn Dressing Blanket 70" x 95"2024-04-0270" x 95"
00840117333048 - XeroBurn Sterile Burn Dressing Blanket 70" x 95"2024-04-02 70" x 95"

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